Ditropan, Kentera (previously oxybutynin nicobrand)(oxybutynin)
Kentera, Oxybutynin, Oxytrol (oxybutynin) is a small molecule pharmaceutical. Oxybutynin was first approved as Ditropan on 1982-01-01. It is used to treat dysuria, neurogenic urinary bladder, and urinary incontinence in the USA. It has been approved in Europe to treat urge urinary incontinence. The pharmaceutical is active against muscarinic acetylcholine receptor M1 and muscarinic acetylcholine receptor M3. In addition, it is known to target muscarinic acetylcholine receptor M4, muscarinic acetylcholine receptor M2, and muscarinic acetylcholine receptor M5.
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Oxybutynin, Oxytrol (discontinued: Ditropan, Gelnique, Oxybutynin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Oxybutynin chloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GELNIQUE | AbbVie | N-022204 DISCN | 2009-01-27 | 1 products, RLD |
| DITROPAN | Johnson & Johnson | N-017577 DISCN | 1982-01-01 | 1 products, RLD |
| DITROPAN XL | Johnson & Johnson | N-020897 DISCN | 1998-12-16 | 3 products, RLD |
| DITROPAN | Johnson & Johnson | N-018211 DISCN | 1982-01-01 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ditropan | New Drug Application | 2012-02-16 |
| gelnique | New Drug Application | 2009-01-15 |
| oxybutynin | ANDA | 2024-12-03 |
| oxybutynin chloride | ANDA | 2026-03-26 |
| oxytrol | New Drug Application | 2024-05-29 |
| oxytrol for women | New Drug Application | 2024-08-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| neurogenic urinary bladder | HP_0000011 | D001750 | N31 |
| urinary incontinence | — | D014549 | R32 |
| dysuria | EFO_0003901 | D053159 | R30 |
Agency Specific
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Clinical
Clinical Trials
110 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 2 | 3 | 8 | 12 | 11 | 36 |
| Urinary incontinence | D014549 | — | R32 | — | 1 | 5 | 5 | 1 | 12 |
| Neurogenic urinary bladder | D001750 | HP_0000011 | N31 | — | 1 | 4 | 3 | 1 | 9 |
| Hyperhidrosis | D006945 | — | — | — | 2 | 2 | 1 | 4 | 9 |
| Urge urinary incontinence | D053202 | EFO_0006865 | N39.41 | — | 1 | 3 | 1 | 3 | 8 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | 2 | 5 | — | 2 | — | 7 |
| Enuresis | D004775 | — | R32 | — | 1 | 3 | 2 | — | 6 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | 1 | 1 | 1 | 1 | 4 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | 2 | — | 1 | — | 3 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | 1 | — | — | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hot flashes | D019584 | — | — | — | 2 | 3 | — | 1 | 6 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 2 | — | — | 2 |
| Hereditary sensory and autonomic neuropathies | D009477 | — | — | — | — | 1 | — | — | 1 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | 1 | — | — | 1 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | — | 1 | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | — | — | 1 | — | — | 1 |
| Carcinoma in situ | D002278 | — | D09.9 | — | — | 1 | — | — | 1 |
| Breast carcinoma in situ | D000071960 | — | D05 | — | — | 1 | — | — | 1 |
| Lobular carcinoma | D018275 | EFO_0000570 | — | — | — | 1 | — | — | 1 |
| Ductal carcinoma breast | D018270 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | 1 | — | — | — | 9 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | 2 | 6 | — | — | — | 6 |
| Apnea | D001049 | — | R06.81 | 1 | 4 | — | — | — | 4 |
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | 1 | 2 |
| Syndrome | D013577 | — | — | — | 2 | — | — | — | 2 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | 1 | 2 |
| Allergic rhinitis | D065631 | — | J30.9 | — | 1 | — | — | — | 1 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | 1 | — | — | — | 1 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | — | — | — | 1 |
| Rhinorrhea | D000086722 | — | — | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | — | — | — | — | 1 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | — | — | — | — | 1 |
| Depression | D003863 | — | F33.9 | 1 | — | — | — | — | 1 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 1 | — | — | — | — | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | — | — | — | — | 1 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | 1 | — | — | — | — | 1 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | 1 | — | — | — | — | 1 |
| Personality disorders | D010554 | — | F60.6 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urologic diseases | D014570 | — | N39.9 | — | — | — | — | 1 | 1 |
| Urinary bladder diseases | D001745 | — | N32.9 | — | — | — | — | 1 | 1 |
| Female urogenital diseases | D052776 | — | — | — | — | — | — | 1 | 1 |
| Anterior cruciate ligament injuries | D000070598 | — | — | — | — | — | — | 1 | 1 |
| Rupture | D012421 | — | — | — | — | — | — | 1 | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | — | — | 1 | 1 |
| Nephrolithiasis | D053040 | — | N20.0 | — | — | — | — | 1 | 1 |
| Kidney calculi | D007669 | EFO_0004253 | N20 | — | — | — | — | 1 | 1 |
| Urolithiasis | D052878 | — | N20-N23 | — | — | — | — | 1 | 1 |
| Ureteral calculi | D014514 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Oxybutynin |
| INN | oxybutynin |
| Description | Oxybutynin is a racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder. It has a role as a muscarinic antagonist, a muscle relaxant, an antispasmodic drug, a parasympatholytic, a calcium channel blocker and a local anaesthetic. It is a tertiary amino compound and a racemate. It contains an esoxybutynin and a (R)-oxybutynin. |
| Classification | Small molecule |
| Drug class | Antimuscarinic |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCN(CC)CC#CCOC(=O)C(O)(c1ccccc1)C1CCCCC1 |
Identifiers
| PDB | — |
| CAS-ID | 5633-20-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1231 |
| ChEBI ID | 7856 |
| PubChem CID | 4634 |
| DrugBank | DB01062 |
| UNII ID | K9P6MC7092 (ChemIDplus, GSRS) |
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Oxybutynin
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Safety
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13,053 adverse events reported
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